Martin Rees-Milton
Velindre NHS Trust
The manufacture of cytotoxic drugs and Systemic Anti Cancer Treatments (SACT) is a high risk process. Within the NHS, drugs are prepared in pharmacy aseptic units to rigorous and highly regulated quality standards, described below. Currently ensuring compliance with Good Manufacturing Practice (GMP) is predominately a manual process, thus subject to the risk human error and potential risk of significant harm to patients.
GMP is the quality system for ensuring that drug products are consistently produced. It is designed to minimize the risks involved in any pharmaceutical production that cannot be eliminated through testing the final product, and covers all aspects of production from the starting materials, premises and equipment to the training and personal hygiene of staff. There must be systems to provide documented proof that correct procedures are consistently followed at each step in the manufacturing process – every time a product is made.
BD Cato is a software program developed by Becton Dickinson, which supports pharmacy manufacturing of SACT drugs whilst maintaining quality standards. It allows the removal of the risks associated with human error; it has been designed to reduce medication errors, waste reduction and automate some of the in-process QA (Quality Assurance) manual checks. It is proposed to pilot BD Cato at the pharmacy department Velindre Cancer Centre.
Interventions and Actions:
Preparing for Pilot:
- Pulling together project team including: (Velindre) IT, Pharmacy. (BD) Account Manager, Solutions Manager, Project Manager.
- Building Database, Drug File and liasing with pharmaceutical companies to get drug information.
- Validation of Data and Systems
- Working with Isolator manufacturer to get equipment ready for pilot
Change management, including:
- Risk analysis
- In depth workflow mapping to ensure safety and a smooth transition to the new ‘to be process’.
- In depth training of team to ensure smooth transition and positive uptake
Anticipated Benefits:
- Continued or improved compliance with GMP
- Provide a standardised aseptic process for NHS Wales
- Reduce the number and time of manual QA steps, potentially increasing the workload capacity of the aseptic unit
- Reduced drug wastage
- Reduction in dispensing errors
This Project Supports Prudent Healthcare:
Impact of people time: The manufacturing of an aseptic product has several Quality Assurance (QA)
in-process manual checks to ensure the final product is prepared to GMP;
It is estimated that these manual checks take 2 minutes per item. Totalling up the daily workload and staff time, the system frees up 2 hours daily across multiple staff groups which will support additional capacity within Velindre Cancer Centre across multiple staff groups, enabling additional workload without additional expenditure.
Error reduction: Analysis from UK NHS aseptic units’ shows that out of 210,000 aseptic items dispensed, these manual in-process QA checks found 1700 errors. Further analysis of these errors indicated that 64% of these errors could have been prevented using an automated software system.
Cost savings: When a drug vial is part used to prepare a dose of SACT for one patient and later the remainder is used to prepare a dose of SACT for another it is termed a Part Used Vial (PUV). If a PUV cannot be reused it must be discarded, an audit at Velindre estimated that £1,500.00 a week is wasted by discarding PUVs. BD Cato is able to schedule the workload to allow the manufacture of the same products consecutively, reducing the PUV wastage.
